Compliance Engineer

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Spectrum Plastics Group, A DuPont Business

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1001 - 5000 employés

🤝 B2B

🔧 Matériel

💊 Pharmaceutique

B2B • Hardware • Pharmaceuticals

Spectrum Plastics Group, une entreprise DuPont, est un fabricant mondial et un partenaire complet qui conçoit, développe et fabrique des composants médicaux spécialisés, des sous-ensembles et des dispositifs finis. L'entreprise fournit des tubulures médicales extrudées, des technologies de cathéters, des ballons médicaux, des moulages par injection de précision (y compris les implantables et les biodégradables), des traitements au laser, et des emballages stériles flexibles, soutenant le développement de produits à travers le prototypage, le support réglementaire/qualité, et la production évolutive pour les clients de dispositifs médicaux et de systèmes d'administration de médicaments. Spectrum dessert une gamme de marchés cliniques et industriels et a été acquise par DuPont, élargissant ainsi ses capacités en emballages et composants médicaux.

Description

• Provide support to Spectrum sites and its customers through leadership in materials documentation for certifications • Establish and maintain a centralized material regulatory statements repository across the Spectrum enterprise • Develop and communicate clear technical and administrative guidance to project teams • Maintain compliance statuses of Spectrum business materials with existing, new or amended regulations • Manage and maintain materials-related sites compliance requirements and reporting obligations • Guide project teams to ensure that design systems fulfil customer expectations and site materials-related regulatory compliance • Streamline and manage regulatory-related customer inquiries response process • Serve as a focal point to and coordinate site responses for the PS&R organization • Collaborate with PS&R to develop responses for any corporate-driven risk and regulatory compliance management • Review existing documents (procedures, work instructions, etc.) for accuracy, robustness, and compliance

🎯 Exigences

• Engineering Degree • 4 years of experience in Quality and/or Compliance Engineering in a manufacturing environment • Supplier Quality Management experience is a plus • Experience with quality systems regulations and standards (ISO 13485, ISO 9001, FDA 21 CFR 820, AS9200, FSSC 22000) • Knowledge of applicable material compliance regulations and standards (EUMDR, REACH regulation (EU)1907/2006, CLP, RoHS, Cal Prop.65, SCIP, WEEE, etc.) • Certification agency (UL, or similar) experience is a plus • Experience using statistical analysis tools • Experience in testing, defect data and data analysis utilizing advanced methods • Excellent computer skills (such as Excel, Word, Access, PowerPoint, SharePoint, etc.) • SAP experience is a plus • Demonstrated ability to lead projects, process execution, and critical issue closure across technical disciplines and organization functions • Demonstrated ability to prioritize tasks and objectives • Demonstrated ability to identify and drive continuous improvements efforts • Strong communication/presentation skills, tailored to audience (oral, written, and/or presentation) including listening

🏖️ Avantages

• Health insurance • Flexible work arrangements